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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00082771 |
Purpose
RATIONALE: SU011248 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well SU011248 works in treating patients with metastatic colorectal adenocarcinoma (cancer) that has not responded to previous treatment with irinotecan, oxaliplatin, and a fluoropyrimidine (such as fluorouracil) with or without bevacizumab.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: sunitinib malate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of SU011248 In Patients With Metastatic Colorectal Cancer Who Have Previously Failed Treatment With Irinotecan, Oxaliplatin, And Fluoropyrimidine, With And Without Bevacizumab |
| Study Start Date: | January 2004 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior bevacizumab (yes vs no).
Patients receive oral SU011248 once daily on days 1-28. Courses repeat every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 2 months for 1 year.
PROJECTED ACCRUAL: A total of 76-126 patients (38-63 per stratum) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have received prior irinotecan, oxaliplatin, and a fluoropyrimidine in the adjuvant and/or advanced disease setting with or without bevacizumab (in the advanced disease setting) AND developed resistance to these prior therapies, as defined by one of the following:
At least one unidimensionally measurable lesion at least 20 mm by conventional radiographic techniques or MRI OR at least 10-16 mm by spiral CT scan
The following lesions are not considered measurable:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following conditions within the past 12 months:
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
At least 3 weeks since prior radiotherapy and recovered
No concurrent radiotherapy to the sole site(s) of measurable disease
Surgery
Other
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Leonard B. Saltz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00082771 History of Changes |
| Other Study ID Numbers: | CDR0000360732, MSKCC-03143, PFIZER-A6181003, PFIZER-PHA-RTKC-0511 |
| Study First Received: | May 14, 2004 |
| Last Updated: | December 13, 2009 |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon |
adenocarcinoma of the rectum recurrent colon cancer recurrent rectal cancer |
|
Adenocarcinoma Colorectal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Oxaliplatin Irinotecan Bevacizumab Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors |